Application based on results from the CheckMate -8HW study, in which Opdivo plus Yervoy demonstrated statistically significant and clinically meaningful improvement in progression-free survival.
Bristol Myers Squibb Co. (BMY) announced Monday that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).